Open
Actively Recruiting
North American Prodromal Synucleinopathy Consortium Stage 2
About
Brief Summary
This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.
Study Type
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria for RBD Group
- Polysomnogram-confirmed RBD by ICSD-3 criteria
- Capable of providing informed consent at time of study enrollment
- Age > 18 years
Exclusion Criteria for RBD Group
- Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
- Narcolepsy-associated RBD
- RBD secondary to any known cause except prodromal synucleinopathy.
- Participation in a clinical trial, except by specific permission by the Executive Committee
- In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
Inclusion Criteria for Control Group
- Ability to provide written consent
- Age > 18 years
- Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site
- Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture.
- Normal capacity to perform complex activities of daily living independently based on informant or physician report
Exclusion Criteria for Control Group
- History of dream enactment behavior to suggest RBD
- Parkinsonism, MSA, dementia, or mild cognitive impairment
- Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning.
- Contraindications to complete MRI.
- Contraindications to lumbar puncture.
- Participation in a clinical trial, except by specific permission by the Executive Committee
- In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
22-000732
Category
Brain/Neurological Diseases
Healthy Volunteers
Principal Investigator
Contact
Location
- UCLA Westwood